Vascular Diagnostic System User Manual Newman Medical 5350 Vivian Street, Unit C Arvada. CO 80002 1-800-267-5549 info@newman-medical.com www.newman-medical.com
COMMON TERMINOLOGY ABI Ankle Brachial Index the ratio of the ankle systolic blood pressure divided by the brachial (arm) systolic blood pressure. DP (or DPA) -- Dorsalis Pedis Artery --- the artery on top of the foot. Used in the ABI exam. MHz Megahertz Millions of cycles per second --the frequency of the sound transmitted by a vascular probe is measured in megahertz - 8 million cycles per second, for example. PAD Peripheral Artery Disease Typically atherosclerosis (also known as hardening of the arteries) in the leg. PPG Photoplethysmography detects the pulse using reflected light from a small emitter/detector combination. PT (or PTA) Posterior Tibial Artery artery on the inside of the ankle used in the ABI exam. PVD Peripheral Vascular Disease Includes venous as well as arterial disease. PVR Pulse Volume Recording a means of evaluating the condition of the arteries by looking at a waveform of small changes in cuff pressure caused by pulses in the arteries under the cuff. Segmentals Pressures and PVRs just like the ABI but done in more cuffs on the leg to assist in localizing the site of any occlusion. The Doppler probe can remain at the ankle for the pressures. TBI Toe Brachial Index the ratio of the pressure in the toe divided by the brachial pressure. It is generally measured with a small toe cuff and a PPG probe
Contents Chapter 1 About simpleabi... 2 Chapter 2 Safety... 2 Chapter 3 Setting up your simpleabi... 3 Chapter 4 simpleabi Reporting Software... 4 Chapter 5 Performing Exams... 6 Chapter 6 - Detailed Description... 12 Chapter 7 Tips & Troubleshooting... 13 Chapter 8 Maintenance and Cleaning... 13 Chapter 9 Specifications... 14 Chapter 10 Warranty, Service, & Support... 16 Page 1 of 16
Chapter 1 About simpleabi Congratulations on your purchase of a simpleabi System from Newman Medical. The simpleabi was designed to be the easiest and most intuitive system on the market for initial vascular assessment. We hope you find that to be the case. If not, please do not hesitate to call us and let us know how we can improve the product for you. What s new in the simpleabi System Simple and intuitive PC based interface Direct to Computer reporting software for ease of reimbursement Chapter 2 Safety Intended Use The simpleabi System was designed to aid in the diagnosis of peripheral arterial disease (PAD) through diagnostic exams including Ankle Brachial Index (ABI). Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner. Contraindications: Do not perform vascular exams on someone suspected of having acute deep venous thrombosis, and do not take an arm pressure in an arm with a shunt or dialysis graft. Warning: The device is not to be used on or near the eyes. Warning: The device is for use only on intact skin. Warning: The device is not to be plugged into a telephone or modem system. Safety of the Blood pressure cuffs Inspect the cuffs for damage periodically. Do not leave a cuff inflated at high pressures for an extended period of time when on a patient. Do not inflate a cuff when it is not on a patient. Cuff covers may be washed by removing the bladders. Any open lesion with the potential for contamination should be covered with an impermeable dressing. Safety of Dopplers The simpleabi was designed according to National and International consensus safety standards. Throughout design of this product, safety was the paramount concern. In view of that, this product was designed according to the principle of ALARA (As Low As Reasonably Achievable). AIUM Statements As Low As Reasonably Achievable (ALARA) Principle Approved March 16, 2008 The potential benefits and risks of each examination should be considered. The ALARA (As Low As Reasonably Achievable) Principle should be observed when adjusting controls that affect the acoustical output and by considering transducer dwell times. Further details on ALARA may be found in the AIUM publication "Medical Ultrasound Safety." Prudent Use and Clinical Safety Approved March 19, 2007 Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: No independently confirmed adverse effects caused by exposure from present diagnostic ultrasound instruments have been reported in human patients in the absence of contrast agents. Biological effects Page 2 of 16
(such as localized pulmonary bleeding) have been reported in mammalian systems at diagnostically relevant exposures but the clinical significance of such effects is not yet known. Ultrasound should be used by qualified health professionals to provide medical benefit to the patient. Safety in Training and Research Approved March 19, 2007 Diagnostic ultrasound has been in use since the late 1950s. There are no confirmed adverse biological effects on patients resulting from this usage. Although no hazard has been identified that would preclude the prudent and conservative use of diagnostic ultrasound in education and research, experience from normal diagnostic practice may or may not be relevant to extended exposure times and altered exposure conditions. It is therefore considered appropriate to make the following recommendation: When examinations are carried out for purposes of training or research, the subject should be informed of the anticipated exposure conditions and how these compare with normal diagnostic practice. Chapter 3 Setting up your simpleabi Installation of your simpleabi is straightforward but may require a few common tools. This installation is typically handled by a trained Newman Medical salesperson. Tools needed: Assembly Directions 1. Remove all materials from packaging. 2. Check that inventory matches packing list. 3. Plug PVR hardware into computer using included USB cable. 4. Use T connector to attach aneroid to PVR hardware and blue tubing. Page 3 of 16
FIELD INSTALLATION OF SIMPLEABI SOFTWARE This section applies only to systems where the software is installed in the field computers shipped from Newman Medical already have the software loaded and this section does not apply. WARNING: simpleabi is only supported on the following Windows Operating Systems: Windows 7 (32 or 64 bit) Windows 10 (32 or 64 bit) Do not install on any other operating systems prior to contacting Newman Medical Technical Support for information. WARNING: Use of other applications (word processing, games, internet) is not an appropriate use of a medical device and must be avoided to ensure proper operation of the simpleabi system. Software Installation Directions 1. Plug in included USB Flash Drive into PC 2. Copy *.msi to C:\ (.msi file will have different names depending on simpleabi system purchased) 3. Double Click *.msi file to begin installation PVR Driver Installation-Windows 7 or Windows 10 1. Plug in PVR box. 2. Click the Windows Start Button (Windows Logo) and type Device Manager 3. Select Device Manager (may be associated with control panel) 4. The simpleabi system will appear under Other Devices, make sure to expand that category to see Newman Medical simpleabi Device 5. Right click Newman Medical simpleabi Device and select Update Driver 6. Choose Browse my computer for driver software 7. In the highlighted field ensure you are browsing the install folder C:\Newman Medical by typing C:\Newman Medical from the field. 8. Make sure Include subfolders checkbox is selected 9. If a Windows Security window appears, select Install 10. Driver should be properly installed and can be checked by opening simpleabi Reporting Software, opening an exam, and clicking any PVR button. a. If installed properly, top of pop-up waveform window will display Connected in green highlight. b. If not installed properly, pop-up waveform window will display Not Connected in red highlight Chapter 4 simpleabi Reporting Software Start-up If the first screen is a windows background that says simpleabi Locked press Enter to get to the desktop. Find the simpleabi Reports icon on the computer desktop and select it. A blank screen with tabs on the top should come on. Select File and then New. Reports systems have a choice of ABI or ABI with Toe exams. Select one and the exam will appear on the screen. Entering Doctor/Examiner/Practice Information Page 4 of 16
Fill in the fields for patient information. Use the touch pad and click on appropriate Risk Factors and Current Symptoms. You may enter information about the physician, examiner, and ICD codes, or you may choose from those available using the drop-down menu feature. You can add or delete items in the drop down choices. Under the EDIT menu and then choose Report Information. You can fill in doctor, examiner, and practice information as you want it to appear on reports. There are some examples pre-filled and you can add, edit, or delete these as you see necessary. To close the Report Information form, select File Close Form Saving Your Exam You can save your finished report using CTRL+S or selecting File Save. Files are appended with Patient ID and a timestamp to differentiate exams. You may also overwrite this default file name. By default, the save command automatically saves the exam in PDF and XML data files. You may select additional file types under Edit Output Formats (TIFF, BMP, JPG, CSV) Printing Your Exam You can print your exams directly to the computer s default printer using CTRL+P or select File Print Help Help is found by selecting the Help Menu. With an internet connection, you will be directed to Newman Medical s home page where you can browse to our support pages with helpful hints and videos on using your simpleabi. Page 5 of 16
Chapter 5 Performing Exams ABI EXAMINATION Overview: The ABI has become the best known and standardized test for PAD. Fundamentally it is the systolic blood pressure taken with the cuff at the ankle divided by the systolic pressure with the cuff on the upper arm. Recent reviews 1 and reimbursement criteria require that the measurements be done with a Doppler using both the DP and PT arteries at the foot. An arterial waveform is also required for reimbursement. Contraindications: Do not perform the ABI exam on someone suspected of having acute deep vein thrombosis, and do not take an arm pressure in an arm with a shunt or dialysis graft. The cuff should not be applied over a distal bypass or over ulcers. Any open lesion posing suspected contamination should be covered with an impermeable dressing or disposable vascular cuffs should be utilized. Have the patient lie down in the supine position relaxed, head and heels supported in a comfortably warm room. Wrap appropriate sized cuffs (usually 12 cm on the arms and 10 cm on the ankles). On the arms apply the cuffs as you would for a normal blood pressure. On the legs, have the patient place their feet flat on the table with knees bent as you apply the cuff above their ankle. Cuffs should fit snugly so that fingers should slide between the cuff and limb with difficulty. The lower edge of the ankle cuff should be about an inch above the top of the medial malleolus (ankle bone). Although the system will allow you to take the pressures and waveforms in any order, try to be consistent. The standard software workflow is to perform the right arm, right ankle, left arm, and finally left ankle. Arm Pressure 1. Connect the hose from the PVR to the first arm cuff. Place the Doppler probe over either the radial (preferred) or the brachial artery. *HINT* Hold the probe close to the end. It also helps to rest your hand on the patient to keep the probe in place. One of the keys to a successful exam is being able to keep the probe in place as you inflate and deflate. If it moves you will not be able to hear the Doppler sounds return and you will have to repeat the inflation. Move the probe slowly back and forth laterally until the strongest arterial signal is heard. 2. Now inflate the cuff until the Doppler signal disappears and continue to inflate for another 10-20mmHg. 3. Slowly (about 2mmHg/second) deflate the cuff. 4. Note the pressure from the aneroid at the moment that you hear the first Doppler arterial sound return and enter that pressure into the brachial pressure box. This is the systolic pressure. 1 Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012;126 Page 6 of 16
Ankle DP Pressure 1. Move the tubing to the ankle cuff. 2. Obtain the ankle pressure at the Dorsalis Pedis (DP). Place the Doppler over the DP artery on the top of the foot. Use light pressure and move the probe laterally to obtain the best signal. The DP is often harder to find; be sure not to press too hard as it is over boney structures and relatively easy to occlude. 3. Now inflate the cuff until the Doppler signal disappears and continue to inflate for another 10-20mmHg. 4. Slowly (about 2mmHg/second) deflate the cuff. 5. Note the pressure from the aneroid at the moment that you hear the first Doppler arterial sound return and enter that pressure into the DP pressure box. Page 7 of 16
Ankle PT Pressure 1. Obtain the ankle pressure at the Posterior Tibial (PT). Place the Doppler over the PT artery near the ankle bone. Use light pressure and move the probe laterally to obtain the best signal, making sure to angle the probe proximally. The PT is often found at the midpoint between the ankle bone and the Achilles tendon. 2. Now inflate the cuff until the Doppler signal disappears and continue to inflate for another 10-20mmHg. 3. Slowly (about 2mmHg/second) deflate the cuff. 4. Note the pressure from the aneroid when you hear the first Doppler arterial sound return and enter that pressure into the PT pressure box. Obtain the PVR Waveform 1. Click on the box that says PVR. 2. Inflate the cuff to about 75 mmhg. Deflate it down to about 65mm and you should see a green visual guide bar on the screen above where the PVR waveform will be. The end of this bar should be about in the middle of the space, not at either end. Adjust it if necessary by inflating or deflating the cuff. 3. Click on the Get Waveform box and wait five seconds while the system gathers waveform data. The waveform will then appear on the report. If it is satisfactory move on, if not just click on the box again to repeat. Visual Guide Bar Page 8 of 16
Left Side 1. Repeat steps above for the left side. The interpretation of the ABI values is based on recent guidelines. 2 *HINT* If the ankle pressure is high, above 200 mmhg, or the cuff cannot obliterate the Doppler sounds, this indicates that the artery may be incompressible due to calcification. SAVING/PRINTING REPORT When finished you may add comments in the comment section and choose Recommendations if desired. Save or print the report by going back to File Save. Interpretation of waveforms Pulse Volume Recording (PVR) is used to measure the change in pressure in the cuff caused by the small changes in volume that occur with each pulse. The analysis of the waveform is based on the shape of the waveform rather than the amplitude. PVRs are not affected by calcified arterial walls and are relatively easy to perform. Normal: Waveforms with a rapid rise and a prominent reflected wave (dicrotic notch) 2 A REPORT OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION/AMERICAN HEART ASSOCIATION TASK FORCE ON PRACTICE GUIDELINES. CIR.0000000000000470, originally published November 13, 2016 Page 9 of 16
Moderately Abnormal: Waveform starts to broaden and no reflected wave. Abnormal: No reflected wave, slow rise. Potential flatline Determining site of occlusion with PVR waveforms: 3 A normal waveform at a site indicates that there is not likely any occlusive disease proximal to that that cuff. Don t be discouraged if measuring the ABI seems slow or clumsy at first. Like any procedure, the ABI becomes easier to do with practice. The ABI with Toe (TBI) Examination Contraindications: Do not perform the ABI with Toe exam on someone suspected of having acute deep venous thrombosis, and do not take an arm pressure in an arm with a shunt or dialysis graft. Background: The ABI with Toe exam is typically performed after an ABI has been done, especially if the larger ankle arteries appear to be incompressible (pressure over 200mmHg) or anytime more information is needed about small vessel disease. The TBI is done using the PPG probe. The patient is supine and rested in a warm room. Setting up On the computer desktop, select the simpleabi icon. To open the ABI with Toe Report, select File New New ABI with Toe Report. The ABI with Toe report form will open on the screen. Wrap cuffs on the arms (typically 12cm). Wrap cuffs on the ankles (typically 10cm) and wrap digit cuffs on the great toes as far down towards the base as possible. Attach the PPG probe and sensor to the DigiDop, replacing the Doppler probe. 3 Daigle, Robert J., Techniques in Noninvasive Vascular Diagnosis, Summer Publishing, www.summerpublishing.com Page 10 of 16
If you have performed a previous ABI Exam, you may load the results into this exam by selecting File Load ABI with Toe Report and selecting the ABI Exam you previously performed. Brachial Pressure 1. Begin with the right brachial. Place the Doppler probe at a 45 degree angle to the skin over the radial or brachial artery. Use plenty of gel and slowly move the probe laterally until the best signal is obtained. (You may also use the PPG sensor to listen for the pulse. If using the PPG, place the sensor on the fleshy part of the finger opposite the fingernail. Wait for consistent beeps from the system.) 2. Using the handheld aneroid, inflate the cuff until you no longer hear the signal - continue for an additional 10-20 mmhg. 3. The thumb button on the aneroid is a variable release mechanism i.e. the more you depress the button the faster the deflation rate. Using the thumb release, deflate at the suggested rate of 2mmHg/second (10mmHg for every 5 seconds may be slightly easier to monitor) 4. When you hear the Doppler signal return, note the pressure from the aneroid. Enter that pressure into the right brachial field on the exam. Ankle Pressures 1. Press tab or use the cursor to move to the Dorsalis Pedis field. Find the arterial signal using the Doppler probe on the dorsalis pedis artery on top of the foot. Obtain the arterial pressure in the same manner you did on the arm. (Using the aneroid, inflate until occlusion + 10-20mmHg, release at 2mmHg/second, note pressure when Doppler signal returns) Page 11 of 16
2. Press tab or use the cursor to move to the Posterior Tibial (PT) field. Find the Doppler signal on the posterior tibial artery. Obtain the arterial pressure in the same manner as other sites. Ankle Waveform 1. Press the PVR button on screen and a pop-up visual guide will appear. This pop-up guides you to correctly inflate the cuff for waveform acquisition. Inflate the cuff to roughly 80mmHg and deflate to roughly 65mmHg. You may take a proper waveform as long as you can see the end of the visual guide bar, as shown above (i.e. pressure is between 55-75mmHg and the visual guide bar is neither completely empty nor completely full) Toe Pressure 1. Press tab or use the cursor to move to the toe pressure field. Find the arterial signal using the Doppler or PPG probe on the toe. Obtain the arterial pressure in the same manner you did on the arm. *NOTE* digit cuffs inflate rapidly. (Using the aneroid, inflate until occlusion +10-20mmHg, release at 2mmHg/second, note pressure when Doppler/PPG signal returns) Toe Waveform 1. Press the PVR button on screen in the toe area and a pop-up visual guide will appear. This pop-up guides you to correctly inflate the cuff for waveform acquisition. Inflate the cuff to roughly 80mmHg and deflate to roughly 65mmHg. You may take a proper waveform as long as you can see the end of the visual guide bar, as shown above (i.e. pressure is between 55-75mmHg and the visual guide bar is neither completely empty nor completely full) Left Side 1. Repeat the above pressures and waveform sequence for the left side of the patient. When finished, save or print the exam. Chapter 6 - Detailed Description DigiDop Doppler Operation and Use The DigiDop is designed to aid in diagnosis of vascular conditions including aiding in obtaining systolic pressures during a vascular examination. Main Unit The body of the unit is a one-piece enclosure. The unit was designed for comfort and ease-of-use during examinations. Each unit is tested to ensure the highest quality possible. Turning unit ON/OFF Power to the unit is controlled by the ON/OFF button located in the center of the unit. Pressing and releasing the button will cycle the unit through the power sequence. The DigiDop automatically turns itself off after 3 minutes of inactivity. This auto shut off feature preserves battery life and serves to eliminate complete battery drain in case of accidental failure to shut off the unit. Battery Monitoring The DigiDop periodically checks the status of the batteries. When the battery symbol on the LCD is half full the batteries are getting low and replacement batteries should be available. When the battery symbol on the LCD flashes, the battery level is low and batteries should be replaced immediately. Page 12 of 16
Volume The DigiDop has multiple volume levels. These are adjusted by sliding the volume slider on the lefthand side of the main unit. Probes: 8 MHz Vascular. simpleabi Systems come standard with an 8MHz probe designed for locating shallow lying vessels. The pen-tip sensor face aids in the location of specific vessels during examination. 5 MHz Vascular. An optional 5MHz probe is available for simpleabi Systems and designed for locating deeper lying vessels. The wider sensors may aid in maintaining the probe location on the vessel during examination. PPG The Photoplethysmograph probe uses the absorption of infrared light by blood cells in the blood to produce an audible beep each time it detects a vascular pulse in the near surface vessels. Obtaining Doppler Signals Caution: For any examination utilizing a Doppler, it is essential that an adequate supply of gel is used to transmit the ultrasound energy from the probe to the surface of the skin. Re-apply more gel if it starts to dry out or spread so thinly that an air gap occurs between the probe and the skin. It is not necessary to cover the entire surface of the probe, only the probe face. Applying too much gel makes the unit difficult to clean and does not aid in the performance of the probe. Given the small area of the vascular probes, the strength of the Doppler signal is highly location specific. Chapter 7 Tips & Troubleshooting Poor Sound Quality Inadequate gel use-apply more gel Probe location-search for vascular sounds as described in Chapter 5 Performing Exams Power Symbol on LCD flashing The voltage of the batteries is low. Charge the batteries as soon as possible. Chapter 8 Maintenance and Cleaning WARNING: The components are not designed for liquid immersion. Do not soak or drop the main unit or probes in liquid. WARNING: The unit not designed for sterilization processes such as autoclaving or gamma radiation. WARNING: The unit is not intended to be used on open skin. If there is evidence of open wound contamination, disinfect the probe before using again as described below. The unit requires very little maintenance. It is important, however, for the continued functionality of the unit and the health of the patients to that the unit is cleaned and examined regularly as follows: After every examination Excess gel should be wiped off after each examination. Unit should be cleaned with a damp water or alcohol based wipe. Mild soap or detergent can be used. In particular pay attention to any surface openings on the unit including, but not limited to, the speaker grill, the battery compartment, the audio output, and the parting line between the front and back shell. Practitioners should wash hands and change gloves after every exam. Please follow local and hospital guidelines for cleaning and disinfection policies. To disinfect unit, use an isopropyl alcohol wipe or spray, such as Parkers Labs Protex and follow the manufacturer s instructions. Store unit in a clean area free from dust and debris in an indoor environment. Page 13 of 16
If storing the unit for a prolonged period of 90 days or longer without use, please remove the batteries prior to storage. Periodically Inspect the unit for signs or cracks or breaks in the surface housing. If any sign of cracking or damage is evident, use of the unit should be discontinued. Please contact Newman Medical for service. Battery Replacement WARNING: Replace rechargeable batteries only with approved batteries. Please call customer service or visit our website for further information. WARNING: The Doppler unit uses AA batteries. Do not attempt to use any other size batteries in the unit. Open the battery compartment by pressing the tab on the battery door and opening the battery compartment. Remove the drained batteries by pulling one of batteries out of the unit from the positive (button) end of the battery. Replace the batteries by paying close attention to the polarity indicators on the battery and the polarity indicators on the battery door. Align the batteries according to the symbols located in the battery compartment. Please note: If the batteries have been incorrectly inserted, the unit will not work, but will NOT be damaged. Please re-insert the batteries correctly. Chapter 9 Specifications Level of Protection against electrical shock Type B Applied Part; Class II Equipment Designed to meet the following standards: IEC60601-1, IEC60601-2, IEC60601-2-37 simpleabi System Weight (inclusive) Transport/Storage Temperature Transport/Storage Humidity 3.6 kgs (8 pounds) -20 ~ 50 C (-4 ~ 122 F) 5% ~ 90%, non-condensing Doppler Unit Dimensions-(h x w x d) 150x65x35 mm (6x2.5x1.25 in) Weight (with probe & batteries) 370 grams (13 ounces) Operating Temperature 10 ~ 40 C (50 ~ 104 F) Operating Humidity 30% ~ 75% Transport/Storage Temperature -20 ~ 50 C (-4 ~ 122 F) Transport/Storage Humidity 5% ~ 90%, non-condensing Battery Voltage, type 3 x 1.5 volts, AA Battery Life 750, 1-minute exams PVR Box Dimensions-imperial (h x w x d) Weight Interface 2.75x2.0x0.8 200 grams (8 ounces) USB, Type B Acoustic Properties (DigiDop) Page 14 of 16
System: Transducer Model: DigiDop 5MHz Operating Mode: Continuous Wave (CW) Application(s): Peripheral Vascular Associated Acoustic Parameters Acoustic Output Global Maximum Value p r.3 W o f c z sp Beam Dimensions PD PRF EBD I SPTA.3 (mw/cm 2 ) I SPPA.3 (mw/cm 2 ) MI 0.0223 86.4 86.4 (Mpa) 0.041 (mw) 9.26 9.26 (MHz) 5.61 5.61 5.61 (cm) 1.10 1.10 1.10 x-6 (cm) 0.154 0.154 y-6 (cm) 0.540 0.540 (usec) CW CW (Hz) n/a n/a Az. (cm) 1.052 Ele. (cm) 0.526 System: Transducer Model: DigiDop 8MHz, narrow Operating Mode: Continuous Wave (CW) Application(s): Peripheral Vascular Associated Acoustic Parameters Acoustic Output Global Maximum Value p r.3 W o f c z sp Beam Dimensions PD PRF EBD I SPTA.3 (mw/cm 2 ) I SPPA.3 (mw/cm 2 ) MI 0.0495 555 555 (Mpa) 0.0923 (mw) 9.02 9.02 (MHz) 7.84 7.84 7.84 (cm) 0.50 0.50 0.50 x-6 (cm) 0.231 0.231 y-6 (cm) 0.121 0.121 (usec) CW CW (Hz) n/a n/a Az. (cm) 0.203 Ele. (cm) 0.457 Measurement Uncertainties: Total uncertainty for power: 28.2% Total uncertainty for ISPTA: 28.2% Total uncertainty for fc: 2.0% Total uncertainty for MI: 14.1% ISPTA.3 ISPPA.3 MI pr.3 Wo fc derated spatial-peak temporal-average intensity (milliwatts per square centimeter). derated spatial-peak pulse-average intensity (watts per square centimeter). The value of IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global maximum MI is reported. Mechanical Index. The value of MI at the position of ISPPA.3, (MI@ISPPA.3) may be reported instead of MI (global maximum value) if ISPPA.3 is 190W/cm2. derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the value reported under MI. ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, Wo is the total timeaverage power; for the operating condition subject to reporting under ISPPA.3, Wo is the ultrasonic power associated with the transmit pattern giving rise to the value reported under ISPPA.3. center frequency (MHz). For MI and ISPPA.3, fc is the center frequency associated with the transmit pattern giving rise to the global maximum value of the respective parameter. For ISPTA.3, for combined modes involving beam types of unequal center frequency, fc is defined as the overall range of center frequencies of the respective transmit patterns. Page 15 of 16
zsp x-6, y-6 PD PRF EBD EDS the axial distance at which the reported parameter is measured (centimeters). are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6 db dimensions in the x-y plane where zsp is found (centimeters). pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of the respective parameter. the pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported value of the respective parameter. the entrance beam dimensions for the azimuthal and elevational planes (centimeters). the entrance dimensions of the scan for the azimuthal and elevational planes (centimeters). The reporting values for ultrasonic power, W0, and non-derated spatial average temporal average ISATA required by paragraph 2.1.2 of the FDA Guidance [3] as well as the derated spatial-peak temporal-average intensity, ISPTA.3, provided for reference only, are calculated for all probes as illustrated in the sample calculations below. For Non-Auto scanning modes reporting parameters are calculated as: W0 = ISPTA.0 * PF ISATA.0 = W0/(entrance beam area) ISPTA.3 = ISPTA.0 * e -0.069 fc z Where ISPTA.0, is the non-derated spatial-peak temporal-average intensity, ISATA.0 is the nonderated spatial-average temporal-average intensity at the transducer face and ISPTA.3, is the derated spatial-peak temporal-average intensity, fc, the waveform center frequency, z, the axial distance between the probe and hydrophone, PF, the power factor which is calculated by integrating the normalized cross axis and raster scan data selecting the largest PF value, which is an effective area used to calculate W0, the ultrasonic power. Chapter 10 Warranty, Service, & Support The simpleabi System and components are guaranteed to be free from defects in material and workmanship for 2 years (5 years for the DigiDop and its probes) from the original sale of the device. This guarantee includes all parts and labor required to repair or replace the unit, including shipping the unit back to the customer. Customer is responsible for the adequate packaging and return of the unit for servicing. Products will be repaired or replaced in a reasonable amount of time, to be determined by service personnel. The manufacturer and distributor of a simpleabi System assume neither responsibility nor liability for incidental or consequential damages arising from the purchase of this product. The manufacturer and distributor of simpleabi Systems are not responsible for damages occurring from misuse or neglectful handling of the device. Any abuse, neglect, or alteration of the equipment, including dismantling of the unit (other than by trained service personnel), from its original specifications nullify all stated and implied warranties. To return a unit for servicing: 1. Call customer service for a return authorization. 2. Clean the product prior to packing and shipping. 3. Adequately package and return the unit to: Newman Medical Attn: Service 5350 Vivian Street, Unit C Arvada, CO 80002 800-267-5549 Page 16 of 16